Note: Descriptions are shown in the official language in which they were submitted.
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INTRAOCULAR LENSES WITH FIXATED HAPTICS
BACKGROUND OF THE INVENTION
In cataract surgery, the practice is to remove the cataractous natural lens
and
replace it with a man-made lens. The replacement lens is placed inside the
natural
capsular bag of the natural human lens. Such replacement of the natural lens
by
artificial intraocular lens is discussed in my Patents Nos. 5,476,514 and
5,047,051.
The present invention represents improvements over my above-mentioned
patents relative to the fixation or anchoring of the lens haptics in the bag,
thereby
overcoming certain potential disadvantages of plate haptic lenses. My Patent
No.
5,047,051 discloses a method of fixing a haptic plate in the capsular bag by
means of
mini-loops at the ends of haptic anchor plates. This enables the bag to
fibrose about
the loops to fix the lens in the bag.
In such procedures, plate haptic lenses without loops or fixation means can
only be implanted in an intact capsular bag with a continuous circular
capsulotomy.
Such plate haptic lenses, if placed into a capsular bag having a tear in the
anterior
capsular rim or posterior capsule, can dislocate with resultant serious
complication of
the surgery.
During the healing and fibrosis process, the anterior capsule rim becomes
fused to the posterior capsule by fibrosis, and a plate haptic with an
appendage thereof
is retained in position by a pocket or tunnel defined by the fibrosis about
the haptic of
appendage portions between the anterior capsular rim and the posterior
capsule.
SUMMARY OF THE INVENTION
As discussed in the foregoing background, a haptic is retained in place by a
pocket or tunnel defined in fibrosis about haptic and appendage portions
between the
anterior capsular rim and the posterior capsule.
The fibrosis fuses together the anterior and posterior capsules, and surrounds
portions of a plate haptic.
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Plate haptic lenses are sometimes desirable because they provide certain
advantages over long loop lenses, including stabilization of the vitreous with
substantially less probability of the most serious complications of cataract
surgery,
these being retinal detachment and cystoid macular edema. Another advantage is
the
consistent posterior location of the optic, which not only stabilizes the
vitreous, but
provides more predictable post-operative, uncorrected visual acuity. A further
advantage is that the posterior location of the lens results in tight contact
of the lens
with the posterior capsule, thereby resulting in reduced rate of specification
of the
posterior capsule with resultant reduced posterior capsulotomy rate.
Improved accommodating intraocular lenses according to the invention
include a central optic having normally anterior and posterior sides and
extended
portions spaced circumferentially about and extending generally radially out
from the
edge of the optic. These extended portions have inner ends joined to the optic
and
opposite outer ends movable anteriorly and posteriorly relative to the optic.
The lens is surgically implanted in the evacuated capsular bag of the lens of
an
eye through the anterior capsule opening in the bag in a position wherein the
lens
optic is aligned with the opening defined by the anterior capsular remnant,
and the
outer ends of the lens distal portions are disposed within the outer perimeter
or cul-de-
sac of the bag. The lens had a radial dimension from the outer end of each
distal or
extended portion to the axis of the lens optic so that with the lens implanted
within the
capsular bag, the outer ends of the extended portions engage the inner
perimetrical
wall of the bag with no or minimal stretching of the bag.
After implantation of the accommodating intraocular lens in the capsular bag,
active ectodermal cells on the posterior surface of the anterior capsule rim
of the bag
cause fusion of the rim to the elastic posterior capsule of the bag by
fibrosis about the
lens extended portions in such a way that these portions are effectively
"shrink-
wrapped" by the fibrous tissue so as to form radial pockets or tunnels in the
fibrous
tissue which contain the haptic portions with their distal ends positioned
within the
cul-de-sac of the capsular bag. the lens is thereby fixated within the
capsular bag with
the lens optic aligned with the opening in the anterior capsule bag. the
anterior
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capsule rim shrinks during fibrosis, and this, combined with fibrosis about
the
extended portions, causes some radial compression of the lens so as to tend to
move
the optic relative to the outer ends of the extended portions in one director
or the other
along the optic axis. The fibrosed, leather-like anterior capsule rim prevents
anterior
movement of the optic and urges it rearwardly during fibrosis. Accordingly,
fibrosis
induced movement of the optic occurs posteriorly to a distant vision position
wherein
either or both the optic and the inner ends of the extended portions press
rearwardly
against and stretch the elastic posterior capsule rearwardly.
During surgery, the ciliary muscle of the eye is paralyzed with a ciliary
muscle
relaxant, i.e., a cycloplegic, such as atropine, to place the muscle in its
relaxed state.
Following surgery, a ciliary muscle relaxant is periodically introduced
throughout a
post-operative fibrosis and healing period (such as two to three weeks) to
maintain
the ciliary muscle in its relaxed state until fibrosis is complete. This drug-
induced
relaxation of the ciliary muscle prevents contraction thereof and immobilizes
the
capsular bag. By this means, the lens optic is fixed during fibrosis in its
distant vision
position with the eye relative to the retina and the lens presses rearwardly
against and
thereby posteriorly stretches the elastic posterior capsule of the capsular
bag. If the
ciliary muscle was not thus maintained in its relaxed state until the
completion of
fibrosis, the ciliary muscle would undergo essentially normal brain-induced
vision
accommodation contraction and relaxation during fibrosis, and the intraocular
lens
would not necessarily fix in the distant position but in some other location
along the
axis of the eye.
The present invention provides haptic lens features which serve to fixate the
distal haptic portions of the lens, thus preventing dislocation and slipping
from the
proper positions in pockets or tunnels formed over the haptic lens features by
fibrosis.
Enlarged and/or distal haptic portions or protuberances are prevented by their
larger
dimension from moving or sliding along pockets or tunnels formed by fibrosis
about
proximally inward haptic portions. The enlarged distal structural features
prevent the
haptic from sliding inwardly relative to such fibrosis pockets to fixate and
prevent
dislocation of the intraocular lens. The enlarged distal structural features
may take
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such forms as: protuberances extending form one or both sides of distal
portions of
plate haptics; flexible extensions extending from distal corners of lens plate
haptics,
which extensions may have protuberances; protuberances extending outwardly
from
spring loops or filamentary loops; enlarged end portions or protuberances on
distal
portions of a plurality of haptics extending from their proximal ends at an
optic;
enlarged wide distal portions of haptics tapered to widen in the distal
direction; prong
protuberances extending laterally outwardly from distal portions of haptics;
and
notches in side edges of distal portions of haptics.
Other preferred embodiments of the invention include extended or distal
protuberances or knobs and openings defined in distal portions of haptics,
which serve
to fixate the distal haptic portions in the periphery of the capsular bag
between the
posterior bag and the anterior capsule remnant b y the fibrosis process
described in the
foregoing Background of the Invention, by the prevention of relative movement
of the
distal portions of the haptics relative to pockets of tunnels formed by
fibrosis about
proximately inward haptic portions. Other preferred embodiments also include
flexible loop haptics extending from disk haptic portions, knobs provided in
the distal
portions of a disk haptic element, openings provided in the distal portions of
a disk
haptic element, and knobs and/or openings provided in the distal portions of a
plurality of plate-type haptics extending from the optic to their distal edge
portions.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is an elevational view of a preferred embodiment of the invention,
showing a plate haptic lens with enlarged protuberances at its distal corners;
Figure 2 is a sectional view taken at 2-2 in Figure l;
Figure 3 is an elevational view of an embodiment of the invention wherein
flexible extensions with protuberances extend diagonally outwardly from distal
corners of haptic plates;
Figure 3A is a sectional view taken at 3A-3A in Figure 3;
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Figure 4 is an elevational view of a haptic plate lens with spring loops
extending outwardly with enlarged portions or protuberances on the loops;
Figure 4A is a sectional view taken at 4A-4A in Figure 4;
Figure 5 illustrates an embodiment of the invention wherein a plurality of
symmetrically tapered haptics extend from wide proximal ends joined to an
optic to
relatively narrow distal ends whereon protuberances are disposed;
Figure SA is a sectional view taken at SA-SA in Figure 5;
Figure 6 is a perspective view of an embodiment wherein each of oppositely-
extending haptics has a distal portion wider than inward or proximal haptic
portions;
Figure 7 is an elevational view of an embodiment of the invention wherein are
shown in partial views two forms of prong protuberances extending laterally
outwardly from distal portions of oppositely extending haptics;
Figure 8 is an elevational view of an embodiment similar to that of Figure 3,
b
y differing in having distal cross-portions at a diagonal extension on each
corner, at
each end of which is disposed a protuberance or knob;
Figure 8A is a sectional view taken at 8A-8A in Figure 8;
Figure 9 is an embodiment similar in certain respects to that of Figure 5 and
differing therefrom in having cross-portions extending from the end of each of
symmetrically tapered haptic portions, each cross-member having a knob or
protuberance at each of its ends;
Figures 10 and 11 are related embodiments having plate-type haptics
extending in the directions from an optic, and having extending therefrom step
portions from which extend or are mounted knobs or protuberances.
Figures 12 to 14 illustrate an embodiment wherein flexible or filament type
loop haptics extend oppositely from an optic and having at the end of each a
knob or
protuberance, Figures 13 and 14 showing the correct manner of engagement of
the
loop end portion and knob in the cul-de-sac of the capsular bag for peripheral
fixation
in the juncture of the posterior capsule and the anterior capsular remnant by
fibrosis,
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and Figure 14 showing an incorrect engagement of an improperly designed end
portion of the loop haptic;
Figure 15 shows an embodiment embodying features of the embodiment of
Figure 12, and having a plurality of knobs spaced apart on oppositely
extending
resilient loop haptics for improved engagement in the cul-de-sac of the
periphery
between the anterior remnant and the posterior capsule;
Figures 16 and 16A show elevational and side views of an embodiment
wherein a disk haptic element has extending therefrom a plurality of flexible
loop
haptics;
Figures 17 and 17A illustrate an elevational and side views of an embodiment
wherein a disk haptic element has extending therefrom a plurality of flexible
loop
haptics having knobs at their outer or distal ends;
Figure 18 shows an embodiment wherein a disk haptic member has defined in
its periphery a plurality of inclined or somewhat tangential prong portions
having
knobs or protuberances at their ends;
Figure 19 is an embodiment having a disk haptic member with a plurality of
knobs or protuberances disposed about its distal edge portion;
Figure 20 is an embodiment wherein a disk haptic member has a plurality of
generally circular openings disposed in its distal edge portions;
Figure 21 shows an embodiment wherein a disk-shaped haptic member has a
plurality of slot openings in its distal edge portion;
Figure 22 is an embodiment wherein a disk-shaped haptic member has
alternating slot openings and knobs disposed in and on its peripheral distal
portion;
Figure 23 shows an embodiment wherein disk haptic portions extend
outwardly from an optic and flexible loop haptic elements with protuberances
thereon
extend from the edges of the disk portions in inclined directions opposite
from the
directions of loop haptics of certain other embodiments;
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Figures 24 to 26 illustrate embodiments wherein a plurality of plate-type
haptics are spaced about an optic, Figure 24 showing slot openings in the
existing
portions of the haptics, Figure 25 showing a plurality of knobs at the distal
portion of
each plate-type haptic, and Figure 26 showing both slot-type openings and a
knob in
the distal portion of each plate-type haptic;
Figures 27 and 28 show embodiments wherein plate-type haptics extend
oppositely from an optic, only one such haptic being shown, Figure 27 showing
an
embodiment wherein slot-type openings are defined in the distal edge portion
of such
haptic element, and Figure 28 showing knobs or protuberances disposed on the
distal
portion of said plate-type haptic;
Figure 29 is a sectional view taken at line 29-29 in Figure 28; and
Figure 30 is a sectional view taken at line 30-30 in Figure 27.
DESCRIPTION OF PREFERRED EMBODIMENTS
The present invention provides distal features of haptics of intraocular
lenses
which serve to fixate the haptic distal portions in the periphery or cul-de-
sac between
posterior capsule and anterior capsular bag remnant of the capsular bag. The
fibrosis
process and procedure for effecting fibrosis about haptic portions are
discussed
hereinbefore in the Background of the Invention.
It is important that distal portions of haptic means be fixated in the
periphery
of the capsular bag between an anterior capsular remnant and the posterior
capsule,
and that such distal portions or features not move relative to pockets or
tunnels
defined by fibrosis about distal haptic features.
With relatively constant movement of lens haptics on optics, there an be
disengagement of distal haptic portions relative to the bag periphery between
the
posterior bag and anterior remnant, if adequate retention is not provided.
Such
disengagement of continued operational force can result if adequate fixation
is not
provided, and can result from such factors as capsular bag shrinkage during
fibrosis
causing a tear to occur in the capsular bag, thus possibly resulting in lens
dislocation
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and the haptic being then positioned in the vitreous in the posterior portion
of the eye,
with serious complications.
The embodiment of the present invention herein described provide distal
haptic features which prevent dislocation of haptics by slipping or shifting
of distal
haptic portions or features relative to fibrosis pockets or tunnels wherein
distally
inward portions of the haptics are disposed.
Referring to the drawings, and particularly to Figure 1, a preferred
embodiment 10 has a distal portion of a plate haptic 12 with protuberances 14
thereon. The sectional view of Figure 2 shows the configuration of the
protuberances
which extend from both sides of haptic 12. A protuberance may extend from only
one
side or surface of the haptic. The protuberances will not pass or slide
through a
fibrosis tunnel or pocket disposed about proximally adjacent smaller
dimensional
portions of the haptic.
Figures 3 and 3A illustrate an embodiment wherein flexible extensions 20
extend diagonally from distal corners of lens plate haptics 22, and have
protuberances
24 at their ends. Extensions 20 position the protuberances laterally and
distally
outwardly of the edges of the haptic, so that they are prevented from moving
or
sliding through a pocket defined by fibrosis about the proximally inward
portions of
the haptics. Figure 3A shows the cross-sectional configuration of the
protuberances.
Figures 4 and 4A illustrate an embodiment 30 wherein protuberances 32
extend outwardly from spring loops or fingers 34 which extend from distal
portions of
plate haptics 36. The protuberances 32 prevent the loop and the distal
portions of the
haptic plates from moving or sliding relative to fibrosis pockets formed about
the loop
and distal haptic portions. Figure 4A shows in cross-section the configuration
of the
protuberances at the ends of the loops. A lens (not shown) generally similar
to that of
Figure 4, may have a loop element attached to a haptic plate, as by fusion of
adhesure,
rather than being integrally formed with the plate.
Figure 5 illustrates an embodiment 40 of the invention wherein a plurality of
haptics 42 are symmetrically tapered outwardly from relatively wide proximal
ends
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joined to an optic 44 to relatively narrow distal ends or forgers whereon
protuberances
46 are disposed. Figure SA shows protuberance details.
Figure 6 illustrates an embodiment 50, which is not an accommodation lens,
wherein each of plate haptics 52 has a wider distal protuberance portions 54
than
proximally adjacent haptic portions. Distal protuberance portions of the
haptics are
defined by tapered haptic configurations which widen in the distal direction.
The
wider distal haptic portion prevents movement of the haptic toward the optic
being
retained against movement relative to the pocket defined by fibrosis about the
plate
haptic inwardly of the distal portion.
Figure 7 illustrates another embodiment 60 of the invention wherein prong
protuberances 62, with prongs 64 with rounded ends, extend laterally outwardly
from
distal portions of plate haptics extending from an optic 66. The prong
protuberances
62 effectively prevent proximal movement toward optic 66 by inward portions of
the
haptics relative to the fibrosis pockets formed about proximally inward
portions of the
haptics.
Figures 1, 3 and 4 to 7 illustrate embodiments of the invention wherein
notches 70 are defined in distal edge portions of plate haptics. Preferably, a
notch 70
is defined in both lateral distal edge portions of a haptic, and such notches
are
preferably defined in lateral edges of the distal portions of at least two
haptics
extending in different directions from an optic. As shown, the notch 70
typically has
an edge portion disposed at a substantial angle to or substantially
transversely of the
side edge or longitudinal axis of the haptic. Such notches and edge portions
are thus
disposed to prevent the haptics from becoming dislocated by preventing
shifting or
sliding thereof relative to fibrosis pockets in which proximally inward haptic
portions
are disposed.
Figures 8 through 30 illustrate embodiments of the invention which provide
protuberances, knobs, openings or haptic means in distal portions for fixating
haptics
in the periphery of the capsular bags between the posterior bags and the
anterior
capsular remnants.
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Figure 8 illustrates an embodiment somewhat similar to that of Figure 3,
wherein there extend from plate haptic portions 74, 76 extensions 78 and cross
portions 80 at either end of each of which is a knob or protuberance 82, shown
in
cross-section in Figure 8A, each extending anteriorly and posteriorly of the
plate
haptic portion. These protuberances are well-positioned for engagement in the
peripheral portion or cul-de-sac of the capsular bag between the posterior bag
and
anterior remnant, thus to prevent haptic movement through any tunnel or pocket
defined by fibrosis about proximately inward haptic portions.
Figure 9 shows an embodiment with a general configuration somewhat similar
to Figure 5, with transverse cross-portions 84 extending from the outer ends
of each
symmetrically tapered haptic, and having disposed at each end of each cross-
portion a
knob 85. The protuberances are well-adapted to extend into the peripheral
portion of
the capsular bag between anterior remnant and posterior bag to fixate the
haptic.
Figures 10 and 11 illustrate embodiments wherein step portions 88, 90 (Fig.
10) are adapted to engage in the peripheral bag portion between the anterior
capsular
rim and the posterior capsule, there being similar haptic portions (not shown)
at the
opposite side of the optic 92. A protuberance or knob 94 depends from step 88
and
extends anteriorly and posteriorly. The steps and the knob 94 are adapted to
be
engaged by fibrosis to fixate the haptic and prevent inward movement of these
components. In the Figure 11 embodiment, step 96 has on its outer end portion
a
knob or protuberance 98, and step 100 has depending from its outer end portion
an
arm from which depends a knob or protuberances 102, the knobs of Figure 11
serving
purposes similar to those of the knob of Figure 10.
Figures 12-14 illustrate embodiments wherein flexible or filamentary loop
haptics 104, 106 of generally arcuate configuration extend oppositely from an
optic
108. Each loop haptic has at its end a knob or protuberance 110 somewhat
similar to
that shown in Figure 8A. The loop haptics extend into the periphery of the bag
between the anterior remnant and the posterior capsule to fixate the haptics
and
prevent movement of the knobs through fibrosis-defined tunnels defined about
the
loops. Figures 13 and 14 illustrate respectively the correct manner for the
loop haptic
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to be oriented to engage the bag periphery wherein a portion of the loop and
the knob
engage the bag periphery. Figure 14 shows an undesirable disposition of the
loop
haptic and knob in the fibrosis which does not provide optimum and desirable
engagement with the bag periphery.
Figure 1 S illustrates an embodiment which is similar to that of Figures 12
and
13 except that a plurality of knobs or protuberances 110, similar to that of
Figure 8A,
are positioned in spaced relation along the loop haptics to provide improved
fixation
of the loop haptic in the peripheral cul-de-sac of the bag.
Figures 16 and 16A show an embodiment having a haptic comprising two half
disk-shaped members 112 from which extend a plurality of loop haptic portions
114.
the edge of the disk-shaped portions and the loops are adapted to fit in the
peripheral
portion of the bag between the capsular remnant and the posterior capsule to
fixate
the haptic.
Figures 17 and 17A illustrate an embodiment which has a disk haptic portion
116 on which are mounted and from which extend a plurality of filament haptic
portions 118 of generally arcuate configuration at the end of each of which is
disposed
a knob or protuberance 120. The loop haptic portions and the knobs serve the
purposes outlined relative to embodiments earlier described.
Figure 18 is an embodiment having a disk haptic 124 wherein are integrally
formed peripheral inclined prong portions 126 extending somewhat tangentially
with
knobs at the ends thereof adapted to fit within the periphery of the bag
between the
anterior capsular remnant and the posterior bag for engagement with the
periphery for
the formation of fibrosis thereabout for the purpose earlier described.
Figure 19 is an embodiment having a disk haptic 130 on the periphery of
which are disposed a plurality of knobs 132, such as the knobs of Figure 28,
to serve
the purposes earlier described in relation to other embodiments.
Figure 20 is an embodiment having a disk haptic 134 with a plurality of
circular openings 136 defined in its distal peripheral portion, the haptic
periphery and
these openings become engaged with fibrosis to serve the purpose earlier
described.
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Figure 21 shows an embodiment similar to that of Figure 20, with slot-shaped
openings 138 defined in disk haptic 140.
Figure 22 is somewhat similar to the embodiments of Figures 19 and 21, and
has slot-shaped openings 138 interspersed with knobs 140 in its disk
peripheral edge
portion.
Figure 23 shows an embodiment wherein disk haptic portions 141 extend
outwardly from an optic, and extending from their distal edge portions are a
plurality
of flexible loop haptic elements 143 with protuberances 145 thereon for
engagement
in the peripheral edge portion of the capsular bag for fixation of the haptic
and
centration of the optic.
Figures 24 and 25 show embodiments each having four plate haptics 142
extending from and equispaced about an optic 144, and having defined in their
peripheral portions slot-shaped openings 145, the haptic edge portion and the
openings being extensible in the bag periphery for purposes earlier described;
the
embodiment of Figure 25 has similarly equispaced haptics extending from an
optic
148, each haptic having a plurality of knobs like those of Figure 29 on its
peripheral
portion, the knobs and haptic edge portions serving the purposes earlier
described.
The Figure 26 embodiment is similar to the embodiment of Figures 24 and 25,
with an optic 150 having four equispaced haptics 152 extending therefrom, each
having slot-shaped openings 154 therein and a knob 156 thereon.
Figures 27 and 28 illustrate embodiments wherein plate-type haptics extend
oppositely from optic 160 in Figure 127, and from optic 162 in Figure 28, the
Figure
27 embodiment having a haptic with slot-shaped openings 164 in its distal
portion,
and the haptics (lower one not shown) of Figure 28 having a plurality of knobs
166 in
its peripheral portion, the slots and the knobs serving the purposes earlier
described.
Figure 29 is a partial sectional view taken at line 29-29 in Figure 28, and
Figure 30 is a partial sectional view taken at line 30-30 in Figure 27.
Thus there have been shown and described novel intraocular lenses with
fixated haptics which fulfill all the objects and advantages sought therefor.
Many
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changes, modifications, variations and other uses and applications of the
subject
invention will, however, become apparent to those skilled in the art after
considering
this specification together with the accompanying drawings and claims. All
such
changes, modifications, variations and other uses and applications which do
not
depart from the spirit and scope of the invention are deemed to be covered by
the
invention which is limited only by the claims which follow.
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